Position Summary:

In support of clinical development programs, the Senior Manager of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities.  Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required. 

Primary Responsibilities:

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Calculate total demand and translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Proposes and implements improvements to assure efficient clinical supply operations.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
• Coordinates CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information.  Maintains departmental reports and files, updates SOPs and other projects as assigned

Education/Experience/Skills

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 4-6 years' experience in pharmaceutical development focused on clinical trial materials
• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
• Proven project management skills
• Ability to handle multiple projects simultaneously
• Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
• Good understanding of IRT system build-up and user testing
• Good negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Good organizational and documentation skills
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Excellent written and verbal communication skills
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Skilled at creating a cooperative team environment
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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As the Senior Director of Regulatory Affairs, you will architect and lead international regulatory strategy and execution to support Corcept’s international commercialization and expansion, starting with Europe. This role ensures all regional and local regulatory requirements are met in cooperation with Corcept functions responsible for clinical research, manufacturing, and commercialization. Staying attuned to the evolving regulatory environment, you will assess and communicate the impact of changes on business and product development programs. At times, you will directly represent Corcept with health authorities in Europe and elsewhere, as our expansion continues.

Responsibilities:

• Develop robust European regulatory plans, aligned with Corcept’s global strategy, that lead to commercialization in new countries 
• Provide regulatory guidance regarding European health authorities and interactions, including EMA 
• Contribute and independently execute the filing plans for Europe in line with corporate, regional, and local business objectives
• Maintain awareness of new and developing legislation, regulatory policy, and technical guidance relating to small molecule therapies across oncology, neurology, endocrinology, and metabolic therapeutic areas, and communicate their implications cross-functionally
• Review and provide strategic input/advice on EU CTR submissions and/or queries  
• Ensure high-quality regulatory submissions are made on time and achieve Corcept’s goals
• Build out a team that oversees regulatory-related launch and post-marketing activities in the EU
• Work closely with the Quality Assurance department on relevant regulatory procedures applicable to the European region

Preferred Skills, Qualifications, and Technical Proficiencies:

• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred
• 12+ years of experience with leading EU and non-EU regulatory submissions and interactions with EMA and national agencies
• Regulatory-related product launch and post-marketing activities experience 
• Experience with and knowledge of European regulatory regulations, directives, and guidelines
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills

Preferred Education and Experience:

• Deep knowledge of European regulatory regulations, directives, and guidelines
• Passionate about strong and to-the-point written work product
• Excellent planning, organization, time, and stakeholder management skills, including the ability to support and prioritize multiple projects
• Strong interpersonal capabilities and ability to build and maintain networks globally
• Possesses a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions

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Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

ClinChoice is searching for an Environmental Healthy and Safety (EHS) Specialist to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE), open to either a temporary employee on a 12 month fixed term contract, or a freelancer.  

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Direct contact for all Environmental, Health and Safety related topics within the facility, for running and future operations.
• Ensure proper follow-up of incidents / good saves within the Business Unit including quality of reporting and investigations, including leading or facilitating incident investigations and reporting outcome to management.
• Coach, lead Environmental, Health and Safety Representatives/Ambassadors on the shopfloor.
• Understand Business Unit Environmental, Health and Safety competency gaps and work with Environmental, Health and Safety Standard Owners on closing these gaps.
• Perform Environmental, Health and Safety assessments within Business Unit projects and changes.
• Participate in internal/external audits and inspections (for example ISO 14001/45001, J&J EHS Comprehensive Audits, governmental agencies) and coordinate the Business Unit preparation for these audits.
• Support and conduct Environmental, Health and Safety related risk assessments like facility, ergonomic, chemical and biosafety risk assessments and mitigation plans.
• Collaborate with the Environmental, Health and Safety department, Biosafety Officer and the Operational Standard Owner.
• Present periodically to the Operation Readiness Team and relevant stakeholders.
• Working pro-actively.
• Monitor the Business Unit Environmental, Health and Safety processes and performance by trend analysis of data and define follow-up.
• Develop multi-year Environmental, Health and Safety strategy and plan for the business unit.

Education, Experience and Skills:

• 2-4 years (operations) experience in a biotechnology or biopharmaceutical industry environment.
• Bachelor’s degree in safety (e.g., HVK, industrial hygiene or equivalent education).
• Proactively sees and finds work, knowing and visibly taking ownership of responsibilities.
• Excellent communication skills, written and verbal in English (required) and Dutch (preferred).
• Stimulating open communication when mistakes are made/problems arise.
• Dares to say no, can deal with uncertainties, escalates clearly and timely, can adapt communication style to the situation, can absorb complex information and views self-improvement as a priority and acts as a role model.
• Recognizes, acknowledges, and involves employees with different backgrounds, talents, knowledge, and ideas.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Environmental Health & Safety, EHS, CRO, Contract Research Organisation, Outsourced, Pharmaceutical, Pharma

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Who we are...

Cell Signaling Technology (CST) is a different kind of life sciences company, one founded, owned, and run by active research scientists, with the highest standards of product and service quality, technological innovation, and scientific rigor for over 20 years. We consistently provide fellow scientists around the globe with best-in-class products and services to fuel their quests for discovery.

Helping researchers find new solutions is our main mission every day, but it's not our only mission. We're also dedicated to helping identify solutions to other problems facing our world. We believe that all businesses must be responsible and work in partnership with local communities, while seeking to minimize their environmental impact. That's why we joined 1% for the Planet as its first life science member, and have committed to achieving net-zero emissions by 2029.

The role

The Senior Field Application Specialist (Sr. FAS) EMEA, Cell Therapy & Regulatory Markets, serves as a trusted scientific partner to customers in the cell therapy, biopharmaceutical and regulated research markets including CMOs and CDMOs. Leveraging deep expertise in CAR-T workflows and GMP/regulatory requirements, this role will empower customers to navigate the transition from discovery to clinical manufacturing. With a strong emphasis on GMP-aligned applications, the FAS provides deep technical expertise, regulatory awareness, and hands-on support to enable successful implementation of CST products in both research and clinical manufacturing environments. Also responsible to reach and/or exceed territory budgetary goals through sales success across key product areas.

You'll have the opportunity to...

• Serve as the primary scientific and technical liaison for customers across EMEA (direct and indirect markets), working in CAR-T and cell therapy development, including GMP and GxP environments
• To be the subject matter expert for customers operating in regulated environments, advising on the selection of CST products that meet cGMP and ISO 13485 quality standards, assay validation, comparability studies, and documentation requirements
• Provide expert pre- and post-sales support on CST products and assays across discovery, translational, and manufacturing workflows
• Support customers operating in regulated markets, including clinical development, quality control, and technology transfer teams
• Partner with the regional commercial team to identify high-value opportunities within the cell and gene therapy (CGT) sector, delivering technical presentations that address the specific pain points of regulatory-market researchers
• Collaborate with Sales, Marketing, Product Management, and R&D to align customer needs with CST product strategy, communicate market trends and regulatory shifts, influencing the development of next-generation reagents for the clinical market
• Support regulatory-driven customer inquiries, including questions related to traceability, reproducibility, lot-to-lot consistency, and change control
• Gather and communicate field insights to internal teams to inform product development and market expansion in the cell therapy space
• Represent CST at scientific conferences, industry meetings, and customer events focused on cell therapy, immuno-oncology, and biomanufacturing
• To drive successful product launches and adoption in EMEA integrating local market specificities including development of sales launch packages, value propositions that are accepted by the sales force and tracking revenue in accordance with forecasts
• To support Early Access Program with sales, marketing, technical support and R&D
• To drive building a KOL network in EMEA, identify customers for possible joint collaborations and facilitate connections with CST R&D
• To work with the global Product Trainer to organize and provide internal training/workshop sessions for EMEA sales representatives and distribution partners.
• Collaborate deeply with the broader EMEA Sales organization and support as needed. This may involve at any time providing people cover for the FAS team in EMEA
• To cultivate a collaborative regional FAS team culture and a strong support system across EMEA

Who you are and what you bring to the team...

• PhD or Master in Cell Biology, Immunology or equivalent 
• 8+ years commercial experience working directly in or supporting GMP/GxP environments within the biopharmaceutical industry
• Hands-on experience in GMP/ GxP environments, including assay development, validation, or manufacturing support
• Deep technical knowledge of CAR-T cell manufacturing processes
• Strong understanding of regulatory expectations in clinical development
• Proven ability to communicate complex scientific concepts to diverse audiences, including scientists, QA/QC, and regulatory stakeholders
• Experience in an international business environment
• Ability to work in a fast-paced environment, manage deliverables and deadlines simultaneously 
• Excellent communication, presentation and organizational skills 
• Ability to adapt scientific communication in the field based on customer needs
• Excellent knowledge of English both in word and writing. Knowledge of additional European languages is highly desirable
• Travel frequently in the field to customers (>60%)

What we offer....

Are you a CRA looking for the best of both worlds?

Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a leading CRO? Our team calls it the best of both worlds — and we think you’ll agree.

ClinChoice is a rapidly growing global contract research organization. We’re currently expanding our CRA network in the Netherlands and looking for talented Clinical Research Associates (CRA II and Senior CRA) interested in partnering with some of the world’s leading pharmaceutical companies in the field of biomedicine.

If that sounds like you, we encourage you to submit your resume via our website — we’d love to hear from you!

Position Overview – Clinical Research Associate
As a CRA, you’ll manage clinical study activities across multiple sites within one or more projects, with a focus on medical devices. You will oversee site performance, conduct company-initiated clinical studies, and ensure high-quality deliverables through site visits, monitoring, and effective communication.

Key Requirements:

• Willingness to travel to sites and surrounding countries (50-80% travel).

• Fluent in Dutch (required for work in the Netherlands).

• Prior experience in monitoring clinical trials and site management.

Join a dynamic, global team that values growth, collaboration, and making a difference in clinical research.

Skills and Qualifications:

• Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Up to 8 years of experience as a CRA.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements.
• Sound knowledge of medical terminology.
• Fluent in English and local language(s).
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).

Education and Experience:

• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science, a Masters or PhD/MD/PharmD.
• At least 4 plus years of onsite monitoring experience is required.
• Previous medical device monitoring experience is required. Therapeutic area experience in neuro- or cardiovascular domain is also required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background – a plus.
• Languages: Be able to converse and monitor in English and Dutch. Must be able to converse and understand the documentation, monitoring, etc. in a reasonably confident manner to monitor in that.
• Ability to travel up to 80% of time.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self-employed, Contract, Site Management, Monitor, Monitoring, Complex Trials, Medical Devices, Cardiology, Neurology, Open to Travel, Submissions, Ethics, Contract Research Organisation, CRO

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Are you a Quality Assurance expert looking for the best of both worlds?

Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a leading CRO? Our team calls it the best of both worlds, and we think you’ll agree.

ClinChoice, a fast-growing global contract research organization, is expanding its Quality Assurance team in the Netherlands. We’re seeking experienced Quality Assurance Specialists focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. Experience within quality and compliance for new products being developed and produced for clinical trials and early launch. Provide QA support for commercial and clinical production at the manufacturing site, serve as the main point of contact for all quality-related matters. Ensure GMP compliance, review manufacturing activities, and collaborate closely with internal teams and external partners across various departments and companies.

Are you interested in partnering with some of the world’s leading pharmaceutical companies in the field of biomedicine? If that sounds like you, we encourage you to submit your resume via our website. We're growing our network and would love to connect with you!

Main responsibilities include:

• Provide quality oversight for the AT production facility and ensure GMP compliance.
• Support GMP processes including change control, documentation, training, and inspection readiness.
• Offer QA guidance on facility/equipment design, tech transfers, validations, aseptic processing, and Annex 1.
• Review investigations, assess non-conformances, and approve CAPAs and product dispositions.
• Support and participate in risk assessments and lead GMP training initiatives.
• Promote a strong quality culture through activities such as GEMBA walks.
• Review and approve document changes and contribute to local/global quality projects.
• Optimize quality monitoring processes and tools.
• Act as QA representative during regulatory inspections and on-call support rotation.
• Partner with site teams to manage changes and mitigate compliance risks.
• Serve as a QA SME for audits, studies, and JBV (quality-related) projects.

Education and Experience:

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
• Depending on education, BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC).
• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
• Proven knowledge of the biotechnological/pharmaceutical industry.
• Proficiency in English both in word and in writing.
• Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines in Operations environment.
• Functions independently in a complex environment to make daily judgments to balance business need, regulatory requirements, and cost efficiency for all Quality decisions. It is required to determine the level of risk, magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management.
• Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities and technical automation.
• Problem solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues.
• Ability to drive collaboration in a fast-paced environment.
• Has good negotiation skills with a customer-oriented attitude. Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints.
• Empowered professional who can make well motivated pragmatic decisions on their own.

The Application Process

• Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

• ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

• Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates.
• ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate i

Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self-employed, Contract, Site Management, Monitor, Monitoring, Complex Trials, Medical Devices, Cardiology, Neurology, Open to Travel, Submissions, Ethics, Contract Research Organisation, CRO

 #LI-VH1 #LI-CONTRACT #LI-1FTE